The Effect of Systemic Dietary Instruction on Management of Plasma Phosphorus Levels in Peritoneal Dialysis (PD) Patients
Primary Purpose
Hyperphosphatemia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
systemic dietary instruction
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia
Eligibility Criteria
Inclusion Criteria:
- Stable on PD for at least three month
- Aged from 18 to 75 years old
- Informed consent approval
Exclusion Criteria:
- Malnutrition (based on SGA results)
- Infection or inflammation within 1 month
- Concurrent wasting disease (i.e. cancer, tuberculosis)
Sites / Locations
- Shanghai Renji Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
interventional group
Arm Description
Outcomes
Primary Outcome Measures
Plasma phosphorus levels
Secondary Outcome Measures
Plasma calcium levels
Carotid artery intima-media thicknesses
Plasma albumin levels
Full Information
NCT ID
NCT01329497
First Posted
April 4, 2011
Last Updated
April 15, 2011
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01329497
Brief Title
The Effect of Systemic Dietary Instruction on Management of Plasma Phosphorus Levels in Peritoneal Dialysis (PD) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Baxter Healthcare Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hyperphosphatemia is highly prevalent in PD patients, and it is an independent risk factor for all-cause and cardiovascular mortality in these patients. Effective treatments are limited in suppressing plasma phosphorous. Because of the nearly linear relationship between protein and phosphorus intake, high dietary protein intake (DPI, 1.2-1.3g/kg/d recommended by KDOQI) would load high phosphorus burden in PD patients. It is suggested that hyperphosphatemia is hard to avoid under such a DPI level, even as the patients take sufficient phosphorus blinders and receive high PD dosage. The present study is to investigate whether systemic dietary instruction would show effects on control of hyperphosphatemia in PD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
systemic dietary instruction
Intervention Description
systemic dietary instruction based on continuous quality improvement (CQI) team-oriented approach
Primary Outcome Measure Information:
Title
Plasma phosphorus levels
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Plasma calcium levels
Time Frame
up to one year
Title
Carotid artery intima-media thicknesses
Time Frame
up to 1 year
Title
Plasma albumin levels
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable on PD for at least three month
Aged from 18 to 75 years old
Informed consent approval
Exclusion Criteria:
Malnutrition (based on SGA results)
Infection or inflammation within 1 month
Concurrent wasting disease (i.e. cancer, tuberculosis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Na Jiang, MD
Phone
+86-21-53882014
Email
jiangjiang198311@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiaqi Qian, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huili Dai, MD
Phone
+86-21-58752345
Ext
3899
Email
dhl_sh@163.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Systemic Dietary Instruction on Management of Plasma Phosphorus Levels in Peritoneal Dialysis (PD) Patients
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